From targeting to immunization, the idea of cancer diagnosis and treatment is constantly evolving, and more new technologies are needed to understand tumors and their microenvironment in detail. Multiplex fluorescence immunohistochemistry (MIHC) technology is a technology that can detect multiple antigens at the same time, provide qualitative and quantitative information, and preserve the intact spatial morphological structure of the sample, so as to achieve multi-dimensional information acquisition, which can better understand the interaction between tumor cells and the surrounding microenvironment, and provide more background information and reference for clinical tumor diagnosis and immunology.
Multiplex fluorescence immunohistochemistry is considered to be the next generation of pathology (NGP) technology, and there is a strong demand for clinical applications. However, the lack of a system is one of the biggest obstacles limiting its widespread clinical application.
Recently, there has been a further breakthrough in the charging standards for medical services related to multiplex fluorescence immunohistochemistry. In September 2023, the National Health Commission, the State Administration of Traditional Chinese Medicine, and the National Bureau of Disease Control and Prevention jointly issued the Notice on Printing and Distributing the Technical Specifications for National Medical Service Projects (2023 Edition), in which multiplex fluorescence immunohistochemistry technology was included, providing a strong boost for the clinical popularization and standardized development of this technology.
Multiplex fluorescence immunohistochemistry system
QuestionIt is gradually resolved
If there is no clear charging standard for emerging clinical laboratory projects, the name of the project will not be available in different regions.
1. Confusion such as non-transparent fees is not conducive to the clinical application and development of innovative technologies. Therefore,** The system is often the first problem to be solved in the clinical application of new technologies.
It is understood that the "Technical Specifications for National Medical Service Projects (2023 Edition)" provides technical support for the scientific calculation of medical service costs and performance management, which is conducive to improving the missing and unclear elements of the current local medical service projects, standardizing the caliber, unifying industry standards, and guiding medical institutions to standardize charging behavior.
Multiplex fluorescence immunohistochemistry technology has been included in the technical specifications of national medical service projects.
The multiplex fluorescence immunohistochemistry technology has been included in the technical specifications of national medical service projects, representing the recognition of its clinical value by the national competent authorities. Next, the project fees and clinical applications related to this technology have been standardized. For such a technology that is at a critical stage of moving from scientific research to clinical practice, the issuance of this document is of great significance.
In addition, multiplex fluorescence immunohistochemistry technology already has a charging standard in Jiangsu Province, which belongs to the "market-regulated price medical project", which is set by the hospital independently.
Multiplex fluorescence immunohistochemistry technology has a charging standard in Jiangsu Province.
Multiplex fluorescence immunohistochemistry is a typical representative of next-generation pathology (NGP) technology, and is also considered to be the next-generation pathology technology that is most likely to achieve clinical implementation. With the improvement of the charging standards of relevant projects in various places, the clinical application of this technology will be accelerated, which is a major benefit for companies such as Kuoran Biotech, which have been deeply engaged in the clinical transformation of multiplex fluorescence immunohistochemistry technology for several years.
It is worth noting that in foreign countries, multiplex fluorescence immunohistochemistry technology has not yet been clearly applied in clinical large-scale application. The improvement of the relevant domestic system will help China lead the world in this track.
Of course, there are multiple factors influencing whether new technologies can be popularized in clinical practice, and in addition to charging standards, medical insurance is also the key. Arterial Network believes that it is feasible to include multiple fluorescence immunohistochemistry technology in medical insurance in the future.
NGS has gone through a tortuous process in the establishment of charging standards and its inclusion in medical insurance, and only a few regions have included NGS in medical insurance until now. This is due to the fact that the difference between the large and small panels of NGS is too large, and the difference between different colors of multiple fluorescence immunohistochemistry technology is not large.
However, it is not easy for new technologies to enter health insurance, and many aspects need to be considered. Next, multiplex fluorescence immunohistochemistry technology needs to continue to establish charging standards in various provinces and cities, complete price declarations, and continue to accumulate clinical evidence to optimize costs.
Multiplex fluorescence immunohistochemistry
ClinicalThe time is ripe for landing
There are a large number of advanced technologies that have clinical value, but have not been included in the list of fees so far. Because, considering the burden of medical care and financial expenditure, ** is more cautious about new charging items.
When applying for a new medical service project, it is generally necessary to prove the innovation, reliability and safety of the new project compared with similar projects, and to issue the identification of clinical research results and the clinical application efficacy certificate signed by the authoritative department. In the context of the epidemic consuming a lot of resources, it is even more difficult to add new medical fees.
Therefore,The newly included clinical test items in the fee catalogue are either accurate enough, or can greatly improve medical efficiency, and have incomparable advantages over conventional technology. Multiplex fluorescence immunohistochemistry combines these advantages.
First of all, multiplex fluorescence immunohistochemistry technology has enabled a deeper and deeper understanding of the tumor microenvironment in clinical practice. Traditional immunohistochemistry technology cannot accurately analyze the correlation between individual proteins and cells, and can only be interpreted qualitativelyImmunofluorescence technology cannot achieve multi-index analysis, and can only label 2-3 indicators;Flow cytometry and genetic testing techniques have lost the in-situ spatial location relationship of the obtained information.
Overall, traditional techniques are unable to simultaneously obtain information about cell composition, cell localization, and cell function in the tumor microenvironment.
Multiplex fluorescence immunohistochemistry technology has achieved a breakthrough in multi-label staining, spectral imaging and intelligent analysis, with the advantages of multi-index quantitative analysis, high sensitivity and specificity, spatial analysis, multi-channel imaging, etc., which can perform immunofluorescence staining on 7-9 biomarkers on a tissue section, quantitatively evaluate the composition, localization and function of cells in tissues, and comprehensively depict the tumor immune microenvironment and in situ spatial information between cells, so as to have a deeper understanding of the mechanism of tumor occurrence and is more likely** The response of the tumor to immunity**, and the accurate screening of the population benefiting from immunity**.
The clinical application of multiplex fluorescence immunohistochemistry technology has obvious advantages.
Secondly, in the context of the uneven distribution of pathological resources and the overload of pathologists, the enthusiasm of hospitals to build digital pathology departments has risen rapidly. The detection throughput of multiplex fluorescence immunohistochemistry technology is controllable, there is no limit on the start-up throughput, and at the same time, through the integration of equipment, reagents, software and services, it can meet the needs of the construction of digital pathologyIt not only helps the pathology department to improve the level of accurate diagnosis and treatment of tumors, but also realizes the interconnection and interoperability of patient data, ensuring the compatibility and integration of systems and data, and the auxiliary diagnosis function of complete patient reporting.
More importantly, the clinical application conditions of multiplex fluorescence immunohistochemistry technology itself are ripe. In 2019, Clearland Biotech started related clinical translational research, and has done a lot of work on product compliance and solution integrity.
Based on multiplex fluorescence immunohistochemistry technology, Clearland has integrated KREEP multi-standard immunofluorescence kit, Krast automatic multi-functional immunohistochemistry staining machine, KR-HT5 high-throughput fluorescence digital pathology scanner, and KRIAS pathology analysis system to form an overall solution for all-round analysis of tumor microenvironment, which can provide complete products and services for clinical practice.
In terms of compliance, in November 2023, the KR-HT5 high-throughput fluorescence digital pathology scanner obtained the first registration certificate for Class II medical devices based on multispectral scanners in China. The company has also obtained 30 filings and production licenses, such as KREEP multi-standard immunofluorescence kit (3 colors, 4 colors, 5 colors, 6 colors, 7 colors, 8 colors, 9 colors), Krast automatic multi-functional immunohistochemistry staining machine (Krast 300, Krast 600).
It can be said that relying on the leading layout of multiplex fluorescent immunohistochemistry product system and compliance, Kuoran Bio has taken the lead in the clinical market.
Policies are issued in succession,
The era of the next generation of pathology is coming
Policy support for the pathology industry is constantly strengthening. According to the statistics of Arterial Network, in the past ten years, China has issued a number of policies on the construction of pathology departments. Among them, the accurate and efficient development of pathological diagnosis technology and digital intelligent pathology are the top priorities of policy attention, which have strongly promoted the development of next-generation pathology technology.
In 2018, the National Hospital Informatization Construction Standards and Specifications (Trial) printed by the National Health Commission put forward clear requirements for pathological information management7 informatization indicators such as specimen packaging, identification, transfer, registration, receiving, checking, and supervision.
In terms of expert consensus, the "Expert Consensus on Non-small Cell Lung Cancer Surgery Based on Molecular Markers" published in the Chinese Journal of Lung Cancer pointed out that multiplex fluorescence immunohistochemistry technology has become one of the important research methods of tumor microenvironment, affirming the clinical value of this technology.
Visible,Driven by a number of favorable factors, multiplex fluorescence immunohistochemistry has stood at the critical point of large-scale clinical application.
ClearNex Bio's multiplex fluorescence immunohistochemistry products have been applied in many hospitals. Due to the differences in the positioning and characteristics of pathology departments in different hospitals, for example, the dominant field of pathology departments in some hospitals is lymphoma, and some are good at lung cancer, and the demand for multiple fluorescent immunohistochemistry products is also different.
For example, a tertiary hospital in Jiangsu Province hopes to develop a multiplex fluorescent immunohistochemistry detection panel based on lymphoma classification, and entrusts Kuoran Bio to conduct customized research and development. At present, the testing protocol customized by Clearland Biotech is already running in the hospital.
Policies have been strengthened, leading enterprises have continued to increase their weight, and the compliance and standardization of multiplex fluorescence immunohistochemistry technology have been accelerated, and the clinical practice has been accelerated. In the future, Kuoran Biotech will continue to focus on tertiary hospitals to further promote the clinical application of multiplex fluorescence immunohistochemistry.